Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant (VITAL-KT)

Improving Dietary Quality and Health Outcomes: A Fruit and Vegetable Voucher Program for Kidney Transplant Patients With Food Insecurity.

This study evaluates the effect of a six-month fruit and vegetable voucher program on satisfaction, dietary quality, and health outcomes among pediatric and young adult kidney transplant recipients experiencing food insecurity.

Study Overview

• Status: Completed
• Conditions: Food Insecurity; Kidney Transplant
• Intervention / Treatment: Other: Fruit and Vegetable Voucher Support Program

Detailed Description

This is a single-arm, prospective interventional study enrolling 18 participants aged 6 to 25 years who have undergone kidney transplantation and screened positive for food insecurity within the past six months.

Participants will receive monthly fruit and vegetable vouchers for six months, distributed via Electronic Benefit Transfer (EBT) cards. The EBT cards, managed by an external partner, will be automatically reloaded monthly and be redeemable at participating retailers.

Data collection will include participant-reported satisfaction surveys post-intervention, food security and dietary quality assessments at baseline and study end, biophysical outcomes (BMI, blood pressure) from routine clinical care, laboratory markers related to kidney and nutritional health (serum potassium, phosphorus, magnesium, albumin, bicarbonate, fasting glucose or HbA1c, and creatinine/GFR), tacrolimus variability to serve as a proxy for medication adherence.

No extra clinical visits or lab draws beyond standard care are required. The findings aim to inform future strategies to address food insecurity in transplant populations.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • UCSF Benioff Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: Children and young adults aged 2 to 25 years who have received a kidney transplant.
• Food Insecurity: Patients who have screened positive for food insecurity (FI) within the past six months, based on the Hunger Vital Sign
• Patients who are currently receiving care at the transplant center and whose caregivers (if the patient is less than 18 years of age) are willing to participate in the intervention.
• Caregivers of non-adult patients

Exclusion Criteria:

• Patient being on a diet consisting of only total parenteral nutrition or tube feeds.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Food Voucher Intervention Arm; Participants in this arm will receive monthly food vouchers in the form of an Electronic Benefit Transfer (EBT) card, which will be mailed to their home and refilled each month for a total of 6 months. The EBT cards are provided and managed by an external community-based organization in partnership with the research team. The voucher amount is intended to supplement household food purchases and reduce food insecurity. The intervention targets pediatric and young adult kidney transplant recipients who have screened positive for food insecurity within the past 6 months. The participants will use the vouchers, and both pre- and post-intervention surveys will be administered to assess food security status and dietary quality. This supportive care intervention is designed to enhance nutritional support and promote stability during the post-transplant period.

Other: Fruit and Vegetable Voucher Support Program; Participants will receive a monthly food voucher in the form of an Electronic Benefit Transfer (EBT) card, mailed to their home and refilled each month for 6 months. The EBT cards are provided and managed by an external community-based organization in partnership with the research team. The intervention is designed to supplement household food purchases, reduce food insecurity, and support nutritional well-being among pediatric and young adult kidney transplant recipients who have recently screened positive for food insecurity. Pre- and post-intervention surveys will be used to assess food security status and dietary quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction Difference	Participant satisfaction with the food voucher program assessed through a survey administered by the end of the 6-month intervention period. This survey will evaluate participants' overall satisfaction with the EBT card, including the perceived impact on food security, ease of use, and the perceived value of the program.	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who screen positively for food insecurity	Food security status will be assessed using a validated food security questionnaire at baseline and post-intervention. This measure will capture changes in household food access and adequacy as a result of the intervention.	From enrollment to the end of treatment at 6 months
Dietary Quality Difference	Dietary quality will be assessed using self-reported dietary intake questions included in the pre- and post-intervention surveys. This measure will provide insight into any changes in the participants' food choices and nutritional habits due to the intervention, focusing on the amount of monthly fruit and vegetable intake.	From enrollment to the end of treatment at 6 months
Number of participants who screen positively for nutrition insecurity	Nutrition security status will be assessed using validated nutrition security questions within the pre- and post-surveys.	From enrollment to the end of treatment at 6 months
Body mass index (BMI) Difference	Weight and height will be combined to report BMI in kg/m^2.	At baseline and 6 months.
Blood pressure difference	Difference of systolic and diastolic blood pressure as measured in mmHg.	From enrollment to the end of treatment at 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Creatinine and GFR difference	Kidney function assessed through serum creatinine and estimated GFR.	From enrollment to the end of treatment at 6 months
Tacrolimus Variability (Proxy for Medication Adherence)	Tacrolimus variability will be assessed by measuring fluctuations in tacrolimus blood levels during the study period. Variability in tacrolimus levels can serve as a proxy for medication adherence in pediatric kidney transplant recipients. Stable tacrolimus levels typically reflect better adherence to prescribed medication regimens, and variability can indicate missed doses or inconsistent adherence.	From enrollment to the end of treatment at 6 months
HbA1c difference	Glycemic control assessed by difference of HbA1c percent (%) values	From enrollment to the end of treatment at 6 months
Serum potassium difference	Difference on serum potassium as measured in mEq/L	From enrollment to the end of treatment at 6 months
Serum magnesium difference	Serum magnesium difference as measured in mg/dL.	From enrollment to the end of treatment at 6 months
Serum bicarbonate difference	Serum bicarbonate difference measured in CO2 content in blood in mEq/L	From enrollment to the end of treatment at 6 months
Changes in medications	Changes in medications such as blood rpessure mendications and supplementation	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Patient-Centered Outcomes Research Institute; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Eva Glenn Lecea, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Ridberg RA, Levi R, Marpadga S, Akers M, Tancredi DJ, Seligman HK. Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality. Nutrients. 2022 Jun 1;14(11):2328. doi: 10.3390/nu14112328.
• Stein R, Finnie RKC, Harmon S, Peng Y, Pritchard C, Vecsey H, Emmons KM, Hargarten S, Simon MA, Blanck HM, Harris DM, Bellows L, Coleman-Jensen A, Fleischhacker S, Koenings MM, Odoms-Young A, Seligman HK, Grant C, Powell A; Community Preventive Services Task Force. Impact of Fruit and Vegetable Incentive Programs on Food Insecurity, Fruit and Vegetable Consumption, and Health Outcomes: A Community Guide Systematic Review. Am J Prev Med. 2025 Mar;68(3):627-637. doi: 10.1016/j.amepre.2024.11.016. Epub 2024 Dec 2.
• Twichell S, Hunt EAK, Ciurea R, Somers MJG; NAPRTCS investigators. Rapid Weight Gain After Pediatric Kidney Transplant and Development of Cardiometabolic Risk Factors Among Children Enrolled in the North American Pediatric Renal Trials and Collaborative Studies Cohort. Pediatr Transplant. 2025 Feb;29(1):e70005. doi: 10.1111/petr.70005.
• Basu S, Akers M, Berkowitz SA, Josey K, Schillinger D, Seligman H. Comparison of Fruit and Vegetable Intake Among Urban Low-Income US Adults Receiving a Produce Voucher in 2 Cities. JAMA Netw Open. 2021 Mar 1;4(3):e211757. doi: 10.1001/jamanetworkopen.2021.1757.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2025
• Primary Completion (Actual): January 20, 2026
• Study Completion (Actual): January 20, 2026

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Kidney Transplant; Patient Satisfaction; Food Insecurity; Dietary Quality; Food Vouchers
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fruit
• Other Study ID Numbers: 25-43473; P0580734 (Other Grant/Funding Number: Agency of Healthcare Research and Quality)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No